MAUDE Adverse Event Report: TEVA PHARMACEUTICAL PARAGARD PARAGARD 380A

Device Problem Component Missing (2306)

Patient Problems Menstrual Irregularities (1959); Abdominal Cramps (2543); Intermenstrual Bleeding (2665)

Event Date 06/25/2013

Event Type  Injury  

Event Description

Patient presented to office with (b)(4) paragard iud in situ requesting to have iud removed as she had become pregnant and wishes to terminate pregnancy. Iud removed with moderate amount traction and found to have missing cross arm, patient had small amount of bleeding then stopped quickly.

• Brand Name: PARAGARD
• Type of Device: PARAGARD 380A
• Manufacturer (Section D): TEVA PHARMACEUTICAL
• MDR Report Key: 3243367
• MDR Text Key: 3687081
• Report Number: 3243367
• Device Sequence Number: 1
• Product Code: HDT

Combination Product (Y/N)

• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: RISK MANAGER
• Type of Report: Initial
• Report Date: 07/03/2013

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/08/2013
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/25/2013
• Device Age: 8 yr
• Event Location: Outpatient DIAGNOSTIC Facility
• Date Report TO Manufacturer: 07/02/2013
• Is this a Reprocessed and Reused Single-Use Device?: No

Patient TREATMENT DATA

Date Received: 07/08/2013 Patient Sequence Number: 1